Neoadjuvant Chemotherapy in NSCLC Stages IB, IIA, IIB, and IIIA/T3
Information source: Rigshospitalet, Denmark
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Non-Small Cell Lung Cancer
Intervention: Carboplatin and Paclitaxel (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Rigshospitalet, Denmark Official(s) and/or principal investigator(s):
Jens B. Sorensen, MD, Study Chair, Affiliation: Dept. Oncology, Rigshospitalet
Summary
Randomised trial of chemotherapy or not before surgery in early resectable stages of NSCLC
(IB, IIA, IIB, and IIIA/N2).
Clinical Details
Official title: Neoadjuvant Chemotherapy in Resectable NSCLC Stages IB, IIA, IIB, and IIIA/T3 But Not IIIA/N2
Study design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Primary outcome: Survival
Secondary outcome: Time to progressionComplete resection rate
Detailed description:
Randomisation between 3 courses of neoadjuvant Carboplatin plus Paclitaxel or no chemotherapy
before surgery.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- NSCLC
- Stages IB, IIA, IIB, IIIA/T3
- Lung function test allowing surgery
- Age 18-75 years
Exclusion Criteria:
- Poor lung function
- Performance status 3-4
- Mediastinal lymph node involvement
Locations and Contacts
Dept. Oncology, Rigshospitalet, Copenhagen 2100, Denmark
Additional Information
Starting date: January 1998
Ending date: January 2006
Last updated: September 8, 2006
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